Aldeyra Therapeutics (ALDX) Leerink’s Global Healthcare Conference 2025 summary

Reproxalap and commercial strategy

• Reproxalap is under NDA review for dry eye disease, with a PDUFA date of April 2 and a co-promotion option with AbbVie involving $194 million in potential upfront and approval payments, plus a 60/40 P&L split favoring AbbVie.

• The drug is differentiated by its rapid onset, potentially working within minutes, and targets redness, a key patient concern not addressed by current chronic therapies.

• AbbVie is actively involved in FDA labeling discussions and has observer rights in regulatory meetings.

• The company will not deploy its own sales force but will leverage KOL relationships and medical education.

• Launch expenses are capped annually, with profitability expected in about three years post-launch.

Pipeline and development plans

• The pipeline includes programs in retina, skin, liver, and immunology, with a focus on RASP modulators for inflammatory and metabolic diseases.

• IND for a RASP modulator injection in dry AMD is targeted for late this year or early next year.

• Intravitreal methotrexate is advancing to a pivotal trial for retinitis pigmentosa, while a lymphoma study is under consideration pending FDA guidance.

• ADX-248, a second-generation oral RASP modulator, is in phase I for atopic dermatitis, with plans for a randomized trial to start late this year or early next.

• Additional programs include metabolic inflammation and alcoholic hepatitis, with further updates expected as funding allows.

Clinical data and rationale

• Open-label trials of ADX-629 in atopic dermatitis and psoriasis showed improvements in PASI and EASI scores, with minimal adverse events and promising efficacy signals.

• The company is prioritizing atopic dermatitis over psoriasis and asthma due to a more open market and unmet need for oral therapies.

• RASP modulators are positioned as master regulators of inflammation, aiming to modulate rather than fully inhibit protein targets.

• Early animal and clinical data suggest potential benefits in metabolic disease, including reductions in triglycerides and synergy with GLP-1s.

• Cash position is $100 million, supporting operations into 2027, with a lean team and flexible program management.